Lifestyle Intervention for Heart Failure

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: NYHA IV heart failure, unsafe exercise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether education and training about exercise can improve the lifestyle of cancer survivors with heart failure symptoms. Participants will receive either usual care or additional support through exercise training (also known as cardiac rehabilitation or physical therapy) and dietary counseling. The goal is to determine if these interventions can positively impact their daily lives. Individuals with heart failure symptoms after chemotherapy who live in the Houston area might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance the quality of life for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these lifestyle interventions are safe for heart failure patients?

Research has shown that exercise is generally safe for people with heart failure. In one study, among more than 300 exercise sessions, only one participant fainted. Exercise also enabled patients to walk longer on a treadmill and improved their overall health.

Similarly, personalized dietary counseling has been found to lower the risk of death in people with heart failure and poor nutrition.

Both exercise and dietary counseling are usually well-tolerated, rarely causing serious side effects. This suggests they are safe options for those looking to improve their heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Intervention for Heart Failure because it explores combining exercise training with dietary counseling, which is not standard in traditional heart failure treatments. Most existing options focus on medications like ACE inhibitors, beta-blockers, and diuretics to manage symptoms and improve heart function. However, this new approach emphasizes lifestyle changes that can potentially enhance overall cardiovascular health by addressing root causes, like poor diet and lack of physical activity. By integrating these non-pharmaceutical interventions, the trial aims to empower patients with sustainable habits that may lead to improved heart function and quality of life.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that exercise and healthy eating can greatly benefit people with heart failure. In this trial, participants in Group 2 will receive Exercise Training combined with Dietary Counseling. Studies have found that exercise boosts fitness levels and quality of life while reducing hospital visits. It strengthens the heart and muscles, making everyday tasks easier. Increasing fruit and vegetable intake can help control symptoms and improve overall health. Together, these lifestyle changes support heart health and enhance well-being. ^{6 7 8 9 10}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer survivors over 18 living in or near Houston, who've finished treatment or are on maintenance chemo. They must have heart failure (NYHA I-III) possibly due to previous chemotherapy and be mentally oriented. Those with severe heart failure (NYHA IV), conditions making exercise unsafe, or unable to consent are excluded.

Inclusion Criteria

I am aware of who I am, where I am, and the current time.

My heart failure was caused by previous chemotherapy.

I have heart failure with symptoms or test results confirming it.

Exclusion Criteria

My heart failure is severe, even with treatment.

Cannot provide informed consent

My doctor says it's unsafe for me to exercise due to my health or current treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including ECG, questionnaires, and exercise tests

1 week

1 visit (in-person)

Treatment

Participants receive either usual care with dietary counseling or exercise training with dietary counseling

16 weeks

3 visits per week (in-person) for exercise group, monthly dietary counseling for usual care group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments and interviews

2-4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Counseling
• Exercise Training

Trial Overview The study examines if lifestyle changes through education about exercise and dietary counseling can improve the lives of those with heart failure post-cancer treatment. Participants will receive either regular care or added training and advice on how to incorporate healthy habits.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 3 Interventions

Exercise Training + Dietary Counseling

Group II: Group 1 Experimental Treatment 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Exercise training is safe and beneficial for patients with heart failure, improving functional capacity, quality of life, and even survival rates, as shown in various studies.

Supervised exercise programs, particularly in cardiac rehabilitation settings, yield the best outcomes due to personalized exercise prescriptions and comprehensive management of patients' health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: a comprehensive program for the management of heart failure. Boudreau, M., Genovese, J.[2019]

A study involving 80 patients with chronic heart failure showed that a structured endurance training program was safe, with no reported adverse events, and led to significant improvements in exercise time and quality of life.

The training increased the anaerobic threshold and decreased the ventilatory equivalent for carbon dioxide during submaximal exercise, indicating enhanced exercise capacity, although it did not significantly improve peak oxygen consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) Wielenga, RP., Huisveld, IA., Bol, E., et al.[2007]

Current evidence on sodium restriction in heart failure is limited, but the ongoing Sodium-HF study aims to provide more definitive results, highlighting the need for high-quality research in lifestyle management.

The GOURMET study showed promising results by integrating sodium restriction with a broader nutritional approach, emphasizing the importance of overall dietary quality and support in improving health outcomes for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sodium restriction in heart failure: where are the data?] Navis, GJ.[2020]

A review of 19 randomized controlled trials on therapeutic patient education for heart failure revealed that while major elements of program descriptions were present, critical information such as patients' educational needs and evaluation methods were often missing.

Improving the precision of program descriptions in future studies could enhance the effectiveness of therapeutic patient education for heart failure patients, suggesting a need for standardized reporting formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? Albano, MG., Jourdain, P., De Andrade, V., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4271268/

Cardiac Rehabilitation Exercise and Self Care for Chronic ... Cardiac rehabilitation (CR) exercise training and CHF self-care counseling have each been shown to improve clinical status and clinical outcomes in CHF.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.124.325533

Exercise Training in Heart Failure: Clinical Benefits and ... This review examines clinical benefits of exercise training across HF subtypes, focusing on clinical trials with key outcomes including mortality, ...

3. nature.com nature.com/articles/s41598-024-82608-z

Effects of exercise based cardiac rehabilitation delivery ... Our analysis identifies HCR (AE + RE) as the most effective intervention for improving quality of life (MLHFQ), exercise capacity (6MWT), and reducing hospital ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2021.01.030

Cardiac Rehabilitation for Patients With Heart Failure In patients with HF, combined endurance-resistance exercise programs significantly improve submaximal exercise capacity, muscle strength, and QOL (2,3). Both ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X24010328

Cardiac Rehabilitation and Heart Failure with Reduced ... In short, there is significant evidence that the quality of life in HF patients can be augmented by exercise. Effect on remodelling, filling pressures, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11719370/

Dietary Interventions in Heart Failure With Preserved Ejection ... Personalized dietary interventions and nutrition support have been shown to significantly reduce mortality in patients with HF and malnutrition.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X24007452

Dietary Interventions in Heart Failure With Preserved ... Personalized dietary interventions and nutrition support have been shown to significantly reduce mortality in patients with HF and malnutrition. •. Medically ...

8. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(22)00272-6/fulltext

Nutritional management of heart failure In the EFFORT trial, individualized nutritional intervention during the acute phase of heart failure also improved short-term outcomes [47]. ...

9. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000001031

2021 Dietary Guidance to Improve Cardiovascular Health Abstract. Poor diet quality is strongly associated with elevated risk of cardiovascular disease morbidity and mortality.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686142/

The Role of Diet and Nutrition in Heart Failure - PubMed Central Prognosis for patients diagnosed with HF remains poor and there is a lack of dietary therapies which have demonstrated an improvement in clinical outcomes, ...